OncoSec and Merck to Evaluate Combination of ImmunoPulse IL-12 and Keytruda for Metastatic Melanoma

OncoSec Medical entered a clinical trial collaboration and supply agreement with Merck to evaluate the combination of OncoSec's ImmuoPulse IL-12 with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a Phase II clinical trial, referred to as PISCES. The planned clinical trial will evaluate the safety and efficacy of the combination in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy.

"We are honored to collaborate with Merck – one of the world's leading cancer immuno-oncology companies – to help bring innovative cancer treatments to patients with unmet medical needs," Punit Dhillon, CEO and President of OncoSec said. "This collaboration is supported by our recent clinical data demonstrating the potential ability of ImmunoPulse IL-12 to rescue patients who do not initially respond to anti-PD-1 therapy in melanoma. In addition to our recent Fast Track Designation for this population, OncoSec is uniquely positioned to meaningfully impact clinical outcomes for patients who do not currently have any other options. By working with innovative immuno-oncology leaders, this alliance underpins OncoSec's strategy to combine our ImmunoPulse IL-12 program with checkpoint inhibitor therapies to advance the care of patients."

Eligible patients for this Phase II study will be those with Stage III/IV metastatic melanoma who are progressing, or have progressed, on previous treatment with an anti-PD-1 therapy. The collaboration agreement is between OncoSec Medical Incorporated and Merck, through a subsidiary. Under the agreement, OncoSec will sponsor and fund the study and Merck will provide Keytruda. Additional details of the collaboration were not disclosed.

PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a Phase II multicenter study of ImmunoPulse IL-12 in combination with Keytruda in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. Eligible patients will be those with Stage III/IV metastatic melanoma who are progressing or have progressed on an approved anti-PD-1 therapy. The primary endpoint for this registration-directed trial will be best overall response rate (BORR).